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Hi there,
Can anybody shed some light on QA responsibilities around csv projects,
Do regualtory bodies expect QA to have the final say/approval before software is released and be impartial to other departments with concern to validation deliverables ?
There are some interesting daft guidance that might help. EMA Guideline on computerised systems and electronic data in clinical trials June 2021. and FDA Digital Health Technologies for Remote Data Acquisition in Clinical Investigations Guidance for Industry, Investigators, and Other Stakeholders DRAFT GUIDANCE Dec 2021. Also the MHRA GCP guide 2012 has stuff on CSV and fit for purpose systems requirements. Also the EMA IWG website has stuff on computer systems in CTs [url]https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-clinical-practice/qa-good-clinical-practice-gcp[/url]. Also the RQA [url]www.theRQA.com[/url] has a whole section about computer systems and a discussion forum on computers in CTs and they run lots of seminars etc [url]https://www.therqa.com/good-practices/it/[/url]
I don't think there is any specific requirement for QA to approve software releases, the issue here is quality control. If your software dev people are following a controlled process (GAMP-based etc), and QA have been involved in approving the process, and perhaps conduct occasional internal audits to ensure the developers are following the approach, then this should be OK. If the release is critically important (maybe you are an EDC vendor?) then it may well be worth getting QA to double check process has been followed to the letter. Pushing out a new version of a clinical trial database on a COTS EDC tool might be something that a trial team can handle. It's all about a proportionate and justifiable approach.
Thanks both